post-market, prospective evaluation of photo-oxidized bovine pericardium in vascular surgery

Conditions: Vascular Diseases; Peripheral Arterial Disease; Hemodialysis Access Failure (Disorder); Carotid Artery Diseases; Abdominal Aortic Aneurism

Summary: the objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving photofix as a patch within a vascular repair or reconstruction procedure.

photofix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques. the primary endpoint for patients with carotid artery stenosis (cas) undergoing carotid endarterectomies (cea) will be rate of ipsilateral central neurologic events; the primary endpoint for all other vascular procedures will be primary patency. the secondary endpoints include all-cause reoperation rate, device-related reoperation rate, explant rate, restenosis rate, secondary patency (hemodialysis access repair (har) only) and survival. a goal of 100 patients will be enrolled at approximately 10 sites. the enrollment period will span a minimum of 8 months from institutional review board (irb) approval and site activation. candidates for this study are adults who require vascular repair or reconstruction surgery that necessitates the use of a patch. patients will be consented pre-operatively and enrolled patients will be followed for approximately 6 months after photofix surgery. data will be collected at 5 time points: baseline (pre-operatively), intra-operatively, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively.

Eligibility criteria:
inclusion criteria: * patient is undergoing a vascular procedure which falls within the indications for use and requires the use of photofix decellularized bovine pericardium * patient's surgery is anticipated to occur within 60 days of consent * patient is ≥18 years old * patient is willing and able to comply with the protocol and follow up period * patient is willing and able to give written informed consent exclusion criteria: * patient's procedure is a revision of a prior arteriotomy or venotomy * patient's procedure requires multiple vascular patches in anatomically distinct regions or other prosthetics (e.g. stents) * patient has a medical history of abnormal coagulopathy, bleeding, or thromboembolic disease * patient has a medical history of severe immunodeficiency disease * patient has a medical history of cancer * patient has severe visceral disease in heart or active liver disease or icterus * patient has a history of cerebrovascular accident (completed stroke) within 3 months of planned surgery * patient has a history of atrial fibrillation and requires a patch for carotid endarterectomy repair * patient has an active or potential infection at the surgical site * patient has used or plans to use immunomodulatory drugs for ≥ 6 months * patient has a sensitivity to products of bovine origin * patient is currently enrolled in another study * patient has a life expectancy of less than 12 months * patient is pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control * patient's procedure is emergent